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Court rules Massachusetts’s ban on painkiller preempted

A federal court in Massachusetts has granted a drugmaker’s request to preliminarily enjoin the commonwealth’s ban on a painkiller, finding that the emergency order was preempted under federal law. Zogenix, Inc. v. Patrick, No. 14-11689 (U.S. Dist. Ct., D. Mass., order entered April 15, 2014). The court concluded that “[w]hen the Commonwealth interposed its own conclusion about [the drug’s] safety and effectiveness by virtue of [the Department of Public Health’s] emergency order,” it obstructed the U.S. Food and Drug Administration’s (FDA’s) congressionally given charge. Specifically, the court found, “the drug Massachusetts wants Zogenix to adopt—Zohydro ER with an ‘abuse-resistant formulation’—has not been approved by the FDA. To satisfy the Commonwealth, Zogenix would be required to return to the FDA and seek approval of a drug different from the one that FDA has already deemed safe.”

Pharmaceutical company Zogenix, Inc. makes an FDA-approved opioid painkiller. It filed a complaint for declaratory and injunctive relief against the Massachusetts governor and Department of Public Health commis- sioner, challenging an emergency order prohibiting medical practitioners in the Commonwealth from prescribing or dispensing “any hydrocodone bitartrate product in hydrocondone-only extended-release formulation,” a product description applying only to the company’s Zohydro™ ER.

According to the complaint, “FDA considered requiring abuse-deterrent technologies for the drug but ultimately concluded that the overall risk-benefit balance of Zohydro™ ER was sufficient to support approval of the NDA [new drug application] without an abuse-deterrent formulation.” The company claims that its drug is needed by patients who are at risk of acetaminophen toxicity. FDA has also allegedly concluded that “the technology used to produce abuse-deterrent opioid formulations ‘is still in the nascent stages’ [and thus] that it is not ‘in the interest of public health at this time to require all opioid products or all [extended release/long- acting] opioid products’ to feature the abuse deterrent formulation.”

Despite this approval and purportedly without warning to the company, the governor issued a press release declaring a public health emergency in March 2014 and directing the Department of Public Health to take action to combat opioid overdoses and giving the commission emergency powers to “[i]mmediately prohibit the prescribing and dispensing of any hydrocodone-only formulation (commonly known as Zohydro) until [it is] determined that adequate measures are in place to safeguard against the potential for diversion, overdose, and misuse..”

According to the court, the company is likely to prevail on the merits, and it further determined that Zogenix had “shown injury to its reputation by defendants’ highly publicized ban of its drug,” and that the ban adversely affects the congressionally mandated arrangement “for ensuring that drugs are safe and effective for those in need.” Balancing the equities, the court stated, “[A]lthough the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers.”The court stayed its order until April 22, 2014.